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Canon Medical System, USA, INC. Recall 87419

Description: System INFX-8000C

Canon Medical System, USA, INC. Recall 87419 Information

Mandated?FDA Mandated
Recall NumberZ-1175-2021
Event ID87419
Event DescriptionSystem INFX-8000C
Product TypeDevices
Quantity272 in total
Recall ReasonThe x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
Device Classification20210317
Device Code InfoModel: CAS-880A, CAS-830B
Center Classification Date20210309
Recall Initiation Date20210205
Recalling FirmCanon Medical System, USA, INC.
Initial Notification Letter
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